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HHS Freezes Rule Affecting Community Health Center’s 340B Drug Discounts
Dinsmore & Shohl LLP, January 2021

The Biden administration implemented a regulatory rule freeze affecting all federal agency rules that had not gone into effect as of Jan. 20, 2021.  At its core, the regulatory rule freeze requires all pending final rules to be delayed at least 60 days in order for the Biden administration to review and opine on the necessity and scope of affected rules. During this delay period, the administration may review, revise, and possibly rescind federal administrative rules...

DOJ Stats Show Dip in Fraud Recoveries in ’20, but Signs Point to Impending Rise in False Claims Act Litigation
Dinsmore & Shohl LLP, January 2021

The U.S. Department of Justice (DOJ) has just released its annual statistical overview[1] of False Claims Act (FCA) and other fraud actions for Fiscal Year 2020 (FY2020)[2], and the numbers tell a mixed story. The total of just over $2.2 billion in settlements and judgments represents a decline of more than one-quarter in recoveries from FY2019,[3] likely reflecting workforce, logistical, and judicial impacts of the COVID-19 pandemic...

California Proposes Significant Change to Limit Use of Short-Form Proposition 65 Warning For Consumer Products
Hanson Bridgett LLP, January 2021

Article PDFJust when businesses thought they had figured out their Proposition 65 compliance strategies, the State of California, through the Office of Environmental Health Hazard Assessment (OEHHA), has proposed a substantial change that will drastically limit the use of the short-form safe harbor warning first authorized in 2018...

Subsidy Control to Replace State Aid
Shoosmiths LLP, January 2021

The EU-UK Trade and Cooperation Agreement has effectively brought an end to state aid and a new regime of subsidy control has come into effect...

Brexit and MedTech, Part 1: Research and Development
Shoosmiths LLP, January 2021

This is the first in our series of articles in which we will look at how Brexit and the EU-UK trade deal impacts research and development. In July 2020, the Government published its Research and Development Roadmap, which sets out the UK’s ambitious long-term objectives for investment in science and research to deliver economic growth and societal benefits across the UK...

International Air Travelers Entering the United States Must Have a Negative COVID-19 Test
Dinsmore & Shohl LLP, January 2021

Effective Jan. 26, 2021, all air passengers traveling to the United States will be required to get a viral test for current infection within the three days before their flight to the U.S. is scheduled to depart, and provide written documentation of their laboratory test results (paper or electronic copy) to the airline...

Massachusetts Health Care Bill Makes Several Significant Changes
Verrill, January 2021

While you were celebrating the New Year, Governor Baker signed Chapter 260 of the Acts of 2020, an “Act promoting a resilient health care system that puts patients first,” the result of the Legislature’s months of work to address various health care delivery system and social equity issues that the COVID-19 epidemic has hastened...

Ohio Court: Injured Workers Cannot Reject Valid Light-Duty Offers Made in Good Faith
Dinsmore & Shohl LLP, January 2021

In the state of Ohio, a light-duty job offer is a strategic way to either bring an injured worker back to the workforce or bar temporary total compensation, should the injured worker reject a valid offer. Either way, it can aid employers in eliminating, minimizing, and/or stopping temporary total disability compensation from being paid in a claim...

Changes to the Standard Method for Assessing Housing Need
Shoosmiths LLP, January 2021

On 12 January 2021, David Mathias, Tim Willis, Sam Grange and Matthew Stimson from our Planning & Environmental team hosted a webinar to discuss the main changes introduced to the existing ‘Standard Method’ used for assessing housing need in England and Wales...

Breach Impacting 9.3M People Leads to $5.1M HIPAA Settlement
Waller, January 2021

The second HIPAA settlement of 2021 is the first traditional enforcement action of the year. And, it’s a big one. Traditionally, OCR enforcement has been triggered by breaches. In 2020, however, we saw a significant increase in a sub-set of Privacy Rule enforcement arising out of the U.S. Department of Health and Human Services’ Office for Civil Rights’ (OCR) patient “Right of Access” initiative...

Federal Government Announces Provider Relief Fund Reporting Extension
Waller, January 2021

The U.S. Department of Health and Human Services (HHS) just announced that Provider Relief Fund Program (PRF) recipients will now be required to submit reports regarding their use of these funds later than previously announced. The previous deadline was February 15, 2021. Currently, a specific new timeline was provided, but HHS is encouraging providers to register to receive updates...

Bulletin Real Time: Latest News
Brigard Urrutia, January 2021

Read the latest news 1. Air travelers arriving to Colombia must provide evidence of a negative PCR test to be allowed entry On December 31st, 2020, the Ministry of Health and Social Protection (Ministerio de Salud y Protección Social) modified the biosecurity protocol for the international air transportation, adding the following measures: Airport operators must prohibit the consumption of food and beverages in immigration or emigration areas...

CDC to Require Negative COVID Tests for All International Air Passengers
Dykema, January 2021

The United States’ Centers for Disease Control and Prevention (CDC) has issued an order that will take effect on January 26, 2021, requiring all arriving international airline passengers to provide proof of a negative COVID test taken within three days of the flight’s foreign departure. For those who have had it, the CDC will require proof of recovery...

USCIS to Select H-1Bs Based on Offered Wage
Dykema, January 2021

The Department of Homeland Security (DHS) has published a new final rule substituting last year’s random selection registration process with one based on the wage offered the worker with those cases with higher wages being more likely to be chosen...

Is the COVID-19 Vaccination in a Child’s Best Interest?
Shoosmiths LLP, January 2021

If parents cannot agree whether their children should be vaccinated, they can make an application under Section 8 of the Children Act 1989 to ask a judge to determine the issue. In M v H (Private Law Vaccination) [2020],  the mother objected to the parties' two children aged six-years-old and four-years-old  being given routine childhood vaccines in accordance with the NHS vaccination schedule...

Ohio’s HB 352 Simplifies and Clarifies Anti-Discrimination Statute
Dinsmore & Shohl LLP, January 2021

On Dec. 22, the Ohio Senate passed the Employment Law Uniformity Act – HB 352. Governor Mike DeWine signed the bill into law on Jan. 12, 2021. The bill is the culmination of 20 years of work by the Ohio Chamber of Commerce to address expansion of Ohio’s anti-discrimination statute resulting from Ohio Supreme Court decisions that interpreted Ohio Revised Code Section 4112 expansively...

New Federal Exceptions Favor Value-Based Care
Dinsmore & Shohl LLP, January 2021

On Nov. 20, 2020, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) issued two final rules, which implement changes to the Anti-Kickback Statute (AKS) and Physician Self-Referral Law (Stark Law) regulations (respectively the OIG Final Rule and the CMS Final Rule, collectively the Final Rules)...

Cambodia: Medical Check-Ups for Cambodian Employees
DFDL, January 2021

The Ministry of Labour and Vocational Training (“MLVT”) issued Prakas 429/20 on 31 December 2020 concerning Medical Check-ups for Cambodian Employees (“Prakas 429”)...

Significant Changes Proposed for Nationwide Permitting
Bradley Arant Boult Cummings LLP, January 2021

2020 was a year of unprecedented circumstances and change, and more change is coming in 2021—this time, in the form of significant modifications to the nationwide permitting program. On September 15, 2020, the Army Corps of Engineers (Corps) published a notice of proposed rulemaking to reissue and modify nationwide permits (NWPs), ahead of the usual five-year reauthorization schedule for the current 2017 NWPs...

Capacity and Lockdown Part 3.0
Shoosmiths LLP, January 2021

The Court of Protection is a specialist Court, focussing solely on supporting vulnerable individuals. This past year has acutely highlighted the needs of those most vulnerable in our society and their dependency on others to help manage their affairs. The Court has had to adjust its practices in order to ensure that help and solutions are found for those lacking capacity with minimal delay...

How will Brexit impact UK IP Rights? Introduction
Shoosmiths LLP, January 2021

Are you concerned about the impact of Brexit on your IP lifecycle? We’ve prepared the following guidance as the introduction to our new Brexit and IP five-part info series where we detail the impacts of Brexit on the various stages of the IP lifecycle. 1...

Proposed HIPAA Changes Promote Patient-Friendly Environment
Waller, January 2021

The regulatory change proposed by the Department of Health and Human Services (HHS) in the recent HIPAA Notice of Proposed Rulemaking (NPRM) is another step toward HHS’s objective to encourage a patient-centric healthcare environment. The HIPAA NPRM proposes to tilt the balance of protecting privacy and facilitating the availability of information toward loosening restrictions on disclosures of patient information...

The Tax System to the Rescue of Print Media
Lavery Lawyers, January 2021

Canadian newspapers' loss of advertising revenues to the hands of internet giants over the past several years has jeopardized the very existence of many such newspapers. In 2018, our governments announced several advantageous tax measures in order to ensure the survival of independent print media...

Buchalter COVID-19 Client Alert: New Treasury PPP Rules Clarify Recent Changes to PPP Program, Extend Time to Obtain a PPP Loan to March 31, 2021
Buchalter, January 2021

  On January 6, 2021, Treasury issued two new Interim Final Rules (IFRs) addressing the new Economic Aid to Hard-Hit Small Businesses, Nonprofits, and Venues Act’s (Act) creation of PPP Second Draw Loans, and the Act’s various changes to PPP requirements generally. The major PPP components of the Act are set forth in detail in Buchalter’s COVID Alert of December 28, 2020 (Buchalter PPP Changes Alert), which can be found here...

Buchalter COVID-19 Client Alert: Congress Incentivizes Rent Deferral During COVID-19 Pandemic Through Bankruptcy Code Amendments in Stimulus Bill
Buchalter, January 2021

In the recently-passed Consolidated Appropriations Act, 2021 (the “Act”), Congress provided much-needed cover for landlords that enter into forbearance agreements with their tenants during the COVID-19 pandemic by protecting landlords from exposure to preference litigation arising out of the deferred rent payments if the tenant were to later file bankruptcy...

 

 

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